The Efficacy and Safety of 17α-Estradiol (Ell-Cranell® alpha 0.025%) Solution on Female Pattern Hair Loss: Single Center, Open-Label, Non-Comparative, Phase IV Study

BACKGROUND: There are several commercially available agents to treat female pattern hair loss (FPHL), including minoxidil solution, anti-androgen agents and mineral supplements. However, these treatments are not always satisfactory. We report the results of a clinical trial of 17α-estradiol (Ell-Cranell® alpha 0.025%) solution to Korean female patients with FPHL. OBJECTIVE: This study was designed to examine the efficacy and safety of Ell-Cranell® alpha 0.025% solution in Korean female patients with FPHL. METHODS: A total of 53 women, 18 to 55 years old, applied topical Ell-Cranell® alpha 0.025% solution once daily for 8 months. Efficacy was evaluated by the change of hair counts and diameter, subjective assessment, and photographic assessment by investigators. RESULTS: Hair counts and diameter from baseline to 4 and 8 months after treatment increased in treated patients and these changes were statistically significant (p<0.0001). 17α-estradiol (Ell-Cranell® alpha 0.025%) solution showed significant improvement by subjective self-assessment and by investigator photographic assessment. Ell-Cranell® alpha 0.025% solution was well tolerated over 8-months period. CONCLUSION: This study showed that Ell-Cranell® alpha 0.025% solution is a safe and effective agent for Korean women with FPHL.